Newsletters

The European Medicines Agency (EMA) publishes newsletters to provide updates on various topics to patients, healthcare professionals and the pharmaceutical industry.

Human medicines highlights

Human medicines highlights, published monthly, contains key information on human medicines and changes to regulatory processes in the past month. These highlights do not cover all the Agency's activities in the area of human medicines.

EMA provides an RSS feed of the human medicines highlights. To subscribe, use the below link and follow our user guide on how to subscribe to RSS feeds:

EMA does not collect any personal data from you when you subscribe to this RSS feed.

SME newsletters

The newsletter for micro-, small- and medium-sized enterprises (SMEs), published four times a year, provides key updates to SMEs on the European regulatory environment.

For older editions, see the Newsletter archive.

What's new in pharmacovigilance

What's new in pharmacovigilance, published four times a year, updates qualified persons for pharmacovigilance on guidance, regulations and events.

Clinical Trials Information System (CTIS) newsflash

EMA's ‘CTIS newsflash’ contains key updates on the latest developments, including system improvements, and links to useful reference materials.

Clinical Trials Highlights

Issues from July 2023 (Issue 15) onwards are available at the link below: 

Previous issues are available on EMA's website in PDF format: 

Veterinary Medicines Highlights

Issues from September 2023 (Issue 13) onwards are available at the link below: 

Previous issues are available on EMA's website in PDF format: 

Big Data Highlights

Issues from June 2023 (Issue 6) onwards are available at the link below: 

•    Big Data Highlights: Issue 6 onwards

Previous issues from 2022 are available on EMA's website in PDF format: 

•    Big Data Highlights: Issues 1 - 5

Electronic Application Form (eAF) - Product Management Service (PMS) newsletter

The electronic Application Form (eAF) - Product Management Service (PMS) newsletter provides pharmaceutical companies and national competent authorities in the EU updates on the progress of the eAF and PMS products. It also includes an overview of upcoming events and information on available resources.

The objective of the eAF product is to replace PDF eAFs used for regulatory submissions with online forms available on the Product Lifecycle Management (PLM) Portal, in order to make completing and handling applications more efficient.

For more information, see:

The Product Management Service (PMS) makes available comprehensive and consolidated data on centrally authorised products (CAPs) and non-centrally authorised products (non-CAPs) from different sources across the European Medicines Regulatory Network.

The data can be re-used in electronic applications and throughout regulatory processes.

For more information, see:

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